在试验协议中报告结果的指导方针:SPIRIT-结果2022扩展
Nancy J Butcher1,2, Andrea Monsour1, Emma J Mew1,3
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
JAMA
|December 13, 2022
概括
新的指导方针通过详细报告结果来加强临床试验方案. 扩展SPIRIT成果2022增加了9个必要的项目,
科学领域:
- 临床试验方法
- 健康研究的透明度
- 科学报告标准
背景情况:
- 试验协议中不一致的结果报告阻碍了监管部门的批准,标准化行为和研究可重复性.
- 现有的结果报告建议各不相同,缺乏协调性,因此需要明确的指导.
研究的目的:
- 制定基于证据和共识的统一标准,用于描述临床试验方案中的结果.
- 扩展标准协议项目:对干预试验的建议 (SPIRIT) 2013年声明,并提供结果具体的报告指南.
主要方法:
- 使用"提高健康研究质量和透明度" (EQUATOR) 方法框架.
- 进行了现有指导的范围审查,专家商,与124名小组成员进行了3轮国际Delphi投票,并与25名小组成员进行了个人共识会议.
主要成果:
- 确定了108个建议,并将它们整合为Delphi投票的56个项目.
- 达成共识的会议产生了9个基本项目,这些项目详细阐述了SPIRIT 2013检查清单中的结果定义,理由,评估和分析.
结论:
- 在SPIRIT-Outcomes 2022扩展中,为临床试验协议提供了9个关键的特定结果项目.
- 这些项目旨在提高试验的实用性,可复制性和透明度,同时尽量减少对结果的选择性不报告.
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